Status:
WITHDRAWN
Rapid Diagnostics for HIV and Hepatitis
Lead Sponsor:
MedMira Laboratories Inc.
Conditions:
HIV Infections
Hepatitis B Infections
Eligibility:
All Genders
13+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine the efficacy of two rapid diagnostic tests in plasma, venipuncture whole blood, and fingerstick whole blood. The clinical performance of Multiplo HBc/HIV/HCV ...
Detailed Description
The objective of this study is to determine the performance characteristics of two rapid diagnostic tests. Approximately 3000-4500 subjects in total will be enrolled in the study into four different ...
Eligibility Criteria
Inclusion
- All subjects:
- 13 years of age or older
- able to sign consent form (or parent/guardian sign consent plus subject sign assent for ages 13-18)
- willing to complete the risk assessment questionnaire, and
- willing to provide blood samples: finger stick sample (2 drops), 1 serum separator tube, 2 anticoagulant (K2 EDTA) tubes.
- Population 1 - Diagnostic Trial "At Risk" Group (n = 2000-3000)
- Subjects must meet one or more of the following inclusion criteria to be enrolled in Population 1:
- Have at least one risk factor for infection with hepatitis B or C,
- Have at least one risk factor for infection with HIV,
- Present with signs and symptoms of hepatitis,
- Be a known HIV-positive individual (previous positive HIV test result, may comprise up to 500 individuals)
- Population 1A - Additional known HIV-positive individuals (n = \~500)
- Subjects must:
- • be a known HIV-positive individual (previous positive HIV test result).
- Population 1B - Additional known HBV-positive individuals (n = \~500)
- Subjects must:
- • be known to have current or past HBV infection, as evidenced by HBV serology results.
- Population 1C - Additional known HCV-positive individuals (n = \~500)
- Subjects must:
- • be known to be infected with HCV, as evidenced by previous positive HCV test results.
Exclusion
- Subjects do not meet the inclusion criteria
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02190305
Start Date
May 1 2014
End Date
August 1 2015
Last Update
April 21 2023
Active Locations (4)
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1
Keck School of Medicine - LAUSC
Los Angeles, California, United States, 90089-9239
2
SCFLD Hepatology Diagnostic Research Laboratory
Miami, Florida, United States, 33136
3
Minneapolis Medical Research Foundation
Minneapolis, Minnesota, United States, 55404
4
NYC Dept Health & Mental Hygiene
New York, New York, United States, 11101